WO2019096033A1 - Endoprothèse de valvule, prothèse de valvule et dispositif de pose - Google Patents
Endoprothèse de valvule, prothèse de valvule et dispositif de pose Download PDFInfo
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- WO2019096033A1 WO2019096033A1 PCT/CN2018/114215 CN2018114215W WO2019096033A1 WO 2019096033 A1 WO2019096033 A1 WO 2019096033A1 CN 2018114215 W CN2018114215 W CN 2018114215W WO 2019096033 A1 WO2019096033 A1 WO 2019096033A1
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- Prior art keywords
- valve
- fixing
- valve prosthesis
- ear
- stent
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Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
- A61F2/2418—Scaffolds therefor, e.g. support stents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/2436—Deployment by retracting a sheath
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/2439—Expansion controlled by filaments
Definitions
- the present invention relates to the field of medical device technology, and in particular to a valve stent, a valve prosthesis and a delivery device.
- aortic valve disease has become one of the common cardiovascular diseases.
- the incidence rate in China is 2%-5%, and it ranks third in Europe and America after coronary heart disease and hypertension.
- Thousands of patients benefit from surgical aortic valve replacement every year, but even in developed countries, there are still a large number of patients with severe aortic valve disease due to advanced disease, advanced age, and multiple comorbidities.
- Aortic valve disease can be caused by congenital defects, natural aging processes, infection or the formation of scars. Over time, calcification may deposit around the aortic valve, resulting in aortic stenosis and/or valvular insufficiency causing "aortic regurgitation.”
- Patients with aortic valve disease are mainly characterized by angina pectoris, syncope and heart failure. The patient's quality of life is seriously degraded, the survival time is significantly shortened, and effective treatment must be performed.
- the percutaneous artificial aortic valve products have been continuously updated and improved.
- the representative products currently used in clinical practice are Edwards valve stent system and CoreValve valve stent system.
- Edwards-SAPIEN bioprosthesis made of bovine pericardium, sutured on a stainless steel (or chrome-plated) stent, using a balloon-expandable stent to position the valve at the annulus, without the need to transport the sheath, can be antegrade, retrograde Or the method of apical approach, the valve for clinical application has two sizes of 23mm and 26mm in diameter.
- An example of such an aortic valve is described in patent application WO200, 149,462 A2.
- the Edwards-SAPIEN aortic valve system has undergone a large number of clinical trials and has obtained very satisfactory results.
- the CoreValve Valve System is another clinically successful valve stent that was first successfully applied to the human body in 2005.
- the artificial valve which is mainly made of three-leaf pig pericardium, is sutured on a nickel-knitted alloy self-expanding stent.
- the stent is currently available in 26mm, 29mm and 31mm sizes.
- An example of such a valve system is given in U.S. Patent Publication No. US 2011/0172765 A1.
- the CoreValve valve stent is made of nickel-chin memory alloy. The upper part of the stent is used to anchor the ascending aorta above the sinus sinus. The radial support force is low.
- the central part of the stent is sewed with leaflets, and its geometry is concave. Coronary blood flow is unobstructed; the lower part of the stent is placed and fixed at the aortic annulus, and its radial support force is strong.
- the latest clinical studies have confirmed that the implantation of the CoreValve valve system not only has good hemodynamic effects, but also a 30-day mortality rate of 8%, indicating an ideal safety.
- the fixed ear of the existing valve prosthesis is a vertically upward structure. Since the fixed ear is larger than the ends of other meshes, when the human body is implanted, the fixed ear and the ascending aortic wall fit together, and the vertical upward structure There is a risk of puncturing the ascending aorta.
- the structure in which the fixed ear is vertically upward is difficult to load at the time of loading, which results in a time-consuming loading. In the course of surgery, the time is life, and the gap of just a few seconds is likely to be the distance between life and death. From this point of view, the drawbacks of fixing the vertical upright structure of the ear are particularly obvious. In the case of TAVR surgery, there is a valve in valve. The design of the fixed ear in the vertical direction is also not conducive to the stability of the implanted second valve.
- the present invention provides a valve stent, comprising: a stent body having a mesh tube shape; and at least two fixing ears, each of which is connected to the stent body and oriented The inside of the bracket body is bent.
- each of the fixing ears includes a first bending section and a second bending section, and the angle of bending the first bending section to the inner side of the bracket body is greater than the second bending section An angle of bending toward an inner side of the bracket main body, the first bent section is closer to the bracket main body than the second bent section in an axial direction of the bracket main body.
- the angle at which the first bending segment is bent toward the inner side of the bracket body ranges from 10° to 45°, and the angle of the second bending segment is bent toward the inner side of the bracket body.
- the range is 5° to 40°.
- the angle at which the second bending segment is bent toward the inner side of the bracket body ranges from 15° to 30°.
- the first bending segment comprises a connecting rod
- the second bending segment comprises a fixing portion
- one end of the connecting rod is connected with the bracket body
- the other end of the connecting rod is fixed with the fixing
- the portion is connected, and one end of the fixing portion away from the connecting rod is a free end.
- the first bending segment includes a first connecting segment
- the second bending segment includes a fixing portion and a second connecting segment connected to the fixing portion, the second connecting segment and the second connecting segment
- One end of a connecting section is connected, and the other end of the first connecting section is connected to the bracket body, and one end of the fixing portion away from the second connecting section is a free end.
- the at least two fixing ears have the same shape and are evenly disposed along the circumferential direction of the bracket body.
- the fixing portion of each of the fixing ears has a through hole.
- the length of the fixing ear is between 1 mm and 6 mm.
- the length of the fixing ear is between 3 mm and 5 mm.
- the fixing ear is manufactured by cutting or knitting.
- the present invention also provides a valve prosthesis comprising a prosthetic valve and a valve support as described above, the artificial valve being secured to the valve support.
- the present invention also provides a delivery device for delivering the above-described valve prosthesis, the delivery device comprising: a sheath tube for receiving a valve prosthesis; an inner tube, the inner tube being disposed at And a fixing head, the fixing head is sleeved on the inner tube, and the fixing head is fixedly connected with the inner tube, and the fixing head is used for defining a fixed ear of the valve prosthesis At the position of the inner tube.
- the guiding tube is disposed outside the sheath tube, the inner surface of the guiding tube is a tapered surface, and the guiding tube can be sleeved on the inner tube.
- the guiding tube is for clamping a fixing ear of the valve prosthesis on the fixing head.
- a plurality of grooves are formed on an outer circumferential surface of the fixing head, and the plurality of grooves are evenly distributed on an outer circumferential surface of the fixing head, and each of the grooves is configured to receive one of the fixings The fixed part of the ear.
- the groove has a bottom, and a shape of a bottom of the groove matches a shape of the fixing portion.
- a bottom of the groove is provided with a boss that matches a through hole provided on a fixing portion of the fixing ear of the valve prosthesis.
- the invention provides a valve stent, a valve prosthesis and a conveying device, which have the following beneficial effects:
- the fixing ear comprises a first bending section and a second bending section
- the angle of bending the first bending section to the inner side of the bracket body is greater than the angle of the second bending section to the An angle at which the inner side of the stent body is bent, in the axial direction of the stent body, the first bending segment is closer to the stent body than the second bending segment, thereby further reducing the valve
- the difficulty of folding the fixation ear and fixing the fixation ear in the delivery device can further save the loading time of the valve support, thereby improving the loading efficiency of the valve prosthesis.
- the fixation of the fixed ear of the valve prosthesis to the inside of the stent body limits the freedom of movement of the second valve prosthesis along the axial direction of the valve prosthesis under the condition of the midvalvular flap, which can effectively reduce the valve prosthesis The risk of shifting.
- Figure 1 is a front elevational view of a valve prosthesis in an embodiment of the present invention
- FIG. 2 is a top plan view of a valve prosthesis in an embodiment of the present invention.
- Figure 3 is a front elevational view of a valve stent in accordance with one embodiment of the present invention.
- FIG. 4 is a partially enlarged schematic view of a valve prosthesis in an embodiment of the present invention.
- Figure 5 is a schematic structural view of a conveying device in an embodiment of the present invention.
- FIG. 6 is a schematic structural view of a fixed ear mounting head of a valve prosthesis according to an embodiment of the present invention.
- Figure 7 is a partially enlarged schematic view showing a fixing head in an embodiment of the present invention.
- Figure 8 is a schematic view showing the structure of a valve prosthesis in the prior art
- Figure 9 is a schematic view showing the structure of a valve prosthesis in an embodiment of the present invention.
- Figure 10 is a schematic illustration of a valve prosthesis implanted in the aorta in accordance with one embodiment of the present invention.
- Figure 11 is a partially enlarged schematic view showing a portion of the valve prosthesis shown in Figure 10 after implantation into the aorta;
- Figure 12 is a schematic view showing a structure in which two valve prostheses are implanted in the aorta according to an embodiment of the present invention
- Figure 13 is a schematic view showing another structure when two valve prostheses are implanted in the aorta according to an embodiment of the present invention.
- Figure 14 is a partial structural view of the two valve prosthesis B in the first state when two valve prostheses are implanted in the aorta in Figure 13;
- Figure 15 is a partial structural view of the two valve prosthesis B in the second state when two valve prostheses are implanted in the aorta in Figure 13;
- Figure 16 is a front elevational view of a valve prosthesis in accordance with yet another embodiment of the present invention.
- Figure 17 is a partially enlarged schematic view showing a fixing ear in still another embodiment of the present invention.
- Figure 18 is a schematic view showing the structure of two valve prostheses implanted in the aorta according to still another embodiment of the present invention.
- Figure 19 is a front elevational view of a valve prosthesis in accordance with another embodiment of the present invention.
- Figure 20 is a front elevational view of a valve prosthesis in still another embodiment of the present invention.
- FIG. 21 is a partially enlarged schematic view showing a fixing ear of a valve prosthesis according to still another embodiment of the present invention.
- Figure 22 is a partially enlarged schematic view of a conveying device in still another embodiment of the present invention.
- 310-bracket body 311-inflow channel structure; 312-transition channel structure; 313-outflow channel structure; 314-stitching ring;
- 320-fixed ear 320a-first connecting end; 321-fixing portion; 322-connecting rod; 323-through hole; 324-first connecting portion; 325-second connecting portion;
- valve stent, valve prosthesis and delivery device of the present invention are further described in detail below with reference to the accompanying drawings and specific embodiments. It should be noted that the drawings are in a very simplified form and all use non-precise proportions, and are only for convenience and clarity to assist the purpose of the embodiments of the present invention.
- the angle at which any one of the fixing ear, the fixing portion, the connecting rod, the first connecting portion and the second connecting portion is bent toward the inner side of the bracket body means the central axis of the valve bracket The angle between the parallel lines.
- FIG. 1 is a front view of a valve prosthesis in an embodiment of the present invention
- FIG. 2 is a plan view of a valve prosthesis in an embodiment of the present invention, the valve prosthesis 100 including artificial Valve 200 and valve support. The artificial valve 200 is secured to the valve support.
- the artificial valve 200 includes a leaflet 210 and a skirt 220.
- the leaflets 210 and the skirt 220 are secured to the valve support by stitching.
- the skirt 220 is used to prevent paravalvular leakage.
- the artificial valve 200 can be a tricuspid valve.
- the valve stent 300 includes a stent body 310 and two fixation ears 320.
- the stent body 310 has a mesh shape.
- Two of the fixing ears 320 are disposed on the bracket body 310, and the two fixing ears 320 are bent toward the inner side of the bracket body 310.
- the fixing lug 320 has a first connecting end 320a, and the first connecting end 320a is connected to the bracket main body 310.
- the fixing lug 320 is located along the bracket main body 310 from the first connecting end 320a. The direction of the central axis extends. That is, in the fixing lug 320, the first connecting end 320a is farthest from the central axis of the bracket main body 310.
- the bracket body 310 includes an inflow channel structure 311, a transition channel structure 312, and an outflow channel structure 313 that are sequentially connected.
- the maximum outer diameter of the outflow channel structure 313 of the bracket body 310 is the largest, and the maximum outer diameter of the transition channel structure 312 is the smallest.
- the outer diameter of the inflow channel structure 311 is from the end far from the transitional path structure 312 to the vicinity. The other end of the transition duct structure 312 gradually becomes smaller.
- the mesh of the outflow channel structure 313 is sparsely wide, while the mesh of the inflow channel structure 311 is denser and narrower.
- the number of meshes of the outflow channel structure 313 is less than the number of meshes of the transition channel structure 312 and the inflow channel structure 311.
- the outer diameters of the inflow channel structure 311, the transition channel structure 312, and the outflow channel structure 313 in this embodiment may be varied in other ways.
- the maximum outer diameter of the inflow channel structure 311 may be located at an intermediate portion of the inflow channel structure 311.
- the grids of the inflow channel structure 311, the transition channel structure 312, and the outflow channel structure 313 in this embodiment may also be changed in other manners, such as the inflow channel structure 311 and the transition channel structure 312.
- the meshes of the outflow channel structure 313 are equal or unequal in size.
- a plurality of sewing rings 314 are disposed on the transition channel structure 312, and the leaflets 210 are sewn at the position of the sewing ring 314.
- the sewing ring 314 is preferably evenly distributed along the axial direction of the valve stent 300.
- the transition channel structure 312 is provided with three sewing rings 314.
- a skirt 220 is sewn to the inflow channel structure 311.
- the material of the skirt 220 can be selected from a medical material having a sealing effect, and the suturing method adopts the existing suturing technique.
- the outflow channel structure 313 is bent away from an end of the transition channel structure 312 toward the inner side of the outflow channel structure 313. Specifically, the outflow channel structure 313 extends from the direction of the central axis away from the stent body 310 from the transition to the transition channel structure 312, and at the maximum outer diameter of the outflow channel structure 313, along the stent body 310. The direction of the central axis extends.
- the fixing ear 320 can be restrained by the shape of the mold, so that the fixing ear 320 as a whole is inclined toward the inner side of the bracket main body 310.
- the angle at which the fixing ear 320 is bent toward the inner side of the stent body 310 is an angle between the parallel line connecting the fixed ear 320 and the central axis of the valve stent 300.
- the fixing ear 320 is The angle between the parallel lines of the central axis of the valve stent 300 is the first angle ⁇ 1.
- the angle at which the fixing lug 320 is bent toward the inner side of the bracket main body 310 is 10° to 45°.
- the angle of bending of the fixed ear 320 to the inner side of the stent body 310 exceeds 45°, the loading of the valve prosthesis 100 will become very difficult, and the fixing ear 320 will be directed into the stent body 310.
- the angle of the side bending is less than 10°, the bending of the fixing ear 320 to the inner side of the bracket body 310 will not be effective. Therefore, in the embodiment, the plurality of fixing ears 320 are directed to the bracket body 310.
- the angle of the inner bend is preferably between 10 and 45 degrees.
- one end of the outflow channel structure 313 away from the transition channel structure 312 is provided with two fixing ears 320 symmetric about the central axis of the valve stent 300 .
- the number of the fixed ears 320 may be three, four or five.
- the number of the fixing ears 320 is preferably two to four.
- a plurality of the fixing ears 320 are preferably evenly disposed along the circumferential direction of the bracket main body 310.
- the plurality of the fixing ears 320 may also be non-uniformly disposed along the circumferential direction of the bracket body 310.
- the shape of the plurality of fixing ears 320 is preferably the same.
- FIG. 4 is a partially enlarged schematic view of a valve prosthesis according to an embodiment of the present invention.
- the fixing ear 320 includes a fixing portion 321 and a connecting rod 322.
- the connecting rod 322 serves as a first bending section of the fixing ear 320
- the fixing portion 321 serves as a second bending section of the fixing ear 320 .
- One end of the connecting rod 322 is connected to the bracket body 310, and the other end of the connecting rod 322 is connected to the fixing portion 321.
- the first connecting end 320 a is an end of the connecting rod 322 connected to the bracket body 310 .
- the fixing portion 321 away from the connecting rod 322 is a free end of the fixing ear 320.
- the fixing portion 321 is preferably flat.
- the first connecting end 320 a is preferably connected to the top end of the mesh on the outflow channel structure 313 , and the fixing part 321 is surrounded by a smooth rounded corner.
- the connecting rod 322 has a rod shape, and the overall width is smaller than the fixing portion 321 .
- the angle at which the first bending segment is bent toward the inner side of the bracket body 310 ranges from 10° to 45°, and the second bending segment is bent toward the inner side of the bracket body 310.
- the angle ranges from 5° to 40°. More preferably, the angle at which the second bending section is bent toward the inner side of the bracket body 310 ranges from 15° to 30°.
- the length of the fixing lug 320 is preferably between 1 mm and 6 mm. Further, the length of the fixing ear 320 is between 3 mm and 5 mm. The fixing ear 320 in the length range facilitates the realization of the bending angle of the fixing ear 320 to achieve a better loading effect.
- the fixing ear 320 and the bracket body 310 are integrally manufactured.
- the mesh tubular stent body 310 and the fixation ears 320 can be cut over a shape memory alloy (typically a nickel titanium alloy) tube and then shaped by a mold.
- the fixing ear 320 and the bracket body 310 can also be separately manufactured, and then the bracket body 310 and the fixing ear 320 are fixedly connected by welding or sewing.
- the valve prosthesis 100 of this embodiment can be implanted into a human body by a delivery device, and it is often necessary to load the valve prosthesis 100 into the delivery device prior to performing the implantation procedure.
- the delivery device 400 includes a sheath tube 410, an inner tube 420, a fixation head 430, and a guide tube 440.
- the sheath tube 410 is used to house the valve prosthesis 100.
- the inner tube 420 is disposed within the sheath tube 410.
- the fixing head 430 is sleeved on the inner tube 420, and the fixing head 430 is fixedly connected to the inner tube 420.
- the fixation head 430 is used to define the position of the fixation ear 320 of the valve prosthesis 100 relative to the inner tube 420.
- the fixed head 430 and the inner tube 420 are movable along the sheath 410.
- the guiding tube 440 is disposed outside the sheath tube 410, and the guiding tube 440 is used to clamp the fixing ear 320 of the valve prosthesis 100 on the fixing head 430.
- FIG. 6 is a schematic structural view of a fixing ear of a valve prosthesis according to an embodiment of the present invention, which is disposed on a fixing head, and the inner tube 420 is composed of a first tube body 421 and a second tube body 422. composition.
- the fixing head 430 is mounted on the first pipe body 421.
- the fixing head 430 is preferably located at an intermediate position of the inner tube 420, that is, where the first tube body 421 and the second tube body 422 are connected. Referring to FIG. 5 and FIG. 6, in this embodiment, the outer diameter of the first tubular body 421 is preferably smaller than the outer diameter of the second tubular body 422. The material of the first tubular body 421 is preferably softer than the second tubular body 422.
- At least two grooves 431 are defined in the outer circumferential surface of the fixing head 430, and the plurality of grooves 431 are preferably evenly distributed on the outer circumferential surface of the fixing head 430.
- FIG. 7 is a partially enlarged schematic view of the fixing head in an embodiment of the present invention, each of the grooves 431 accommodating a fixing portion 321 of the fixing ear 320.
- the groove 431 has a bottom 432, and the shape of the bottom 432 of the groove 431 matches the shape of the fixing portion 321 .
- the bottom surface 432 of the groove 431 is a first curved surface
- the inner side of the fixing portion 321 of the fixing ear 320 is a second curved surface
- the first curved surface and the second curved surface may overlap at least partially.
- the first curved surface is bonded to the second curved surface.
- the depth of the groove 431 is greater than the thickness of the fixing ear 320 by 0 to 0.4 mm.
- the outer contour of the fixing head 430 away from the one end of the second tubular body 422 is larger than the outer diameter of the first tubular body 421 , thereby forming a convex protruding from the outer surface of the first tubular body 421 .
- the inner surface 441 of the guide tube 440 is a tapered surface.
- the guide tube 440 has a first end 442 and a second end 443.
- the first end 442 is located at a large diameter end of the inner surface 441 of the guiding tube 440
- the second end 443 is located at a small diameter end of the inner surface 441 of the guiding tube 440.
- the process of loading the valve prosthesis 100 into the sheath 410 of the delivery device 400 is as follows:
- valve prosthesis 100 is placed in ice water, and the guiding tube 440 is placed over the valve prosthesis 100 such that the fixing ears 320 of the valve prosthesis 100 are gathered by the guiding tube 440.
- the inner tube 420 is inserted into the valve prosthesis 100 and the guiding tube 440 from the side of the valvular prosthesis 100 having the fixed ear 320, so that the valve prosthesis 100 and the guiding tube 440 are sleeved on the inner tube 420.
- the position of the valve prosthesis 100 and the guide tube 440 is adjusted such that the fixation ears 320 of the valve prosthesis 100 correspond one-to-one with the position of the recess 431 on the fixation head 430, and then the guide tube 440 is brought closer to the sheath 410.
- the direction of movement is such that the fixing ears 320 are further gathered.
- the direction of movement of the guiding tube 440 can be reversed in a direction opposite to the direction indicated by the first arrow J1 in FIG. 6 until the fixing ear 320 is clamped to the fixing head.
- the retaining ear 320 of the valve prosthesis 100 is now just touching the bottom 432 of the recess 431 of the fixed head 430.
- the outflow channel structure 313 of the valve prosthesis 100 may be firstly offset from the convex surface of the fixed head 430 by one end of the transition channel structure 312, and then passed through the rotating guide tube 440 and the valve prosthesis 100. The way to fix the position of the ear 320 is adjusted.
- the moving direction of the sheath tube 410 can be referred to the first arrow J1 in FIG. direction.
- FIG. 8 is a structural schematic view of the valve prosthesis in the prior art
- FIG. 9 is a valve prosthesis loading in an embodiment of the present invention.
- the valve prosthesis 100 has a released state and a crimped state. In the released state, the valve prosthesis 100 is flared into a petal-like shape.
- the valve prosthesis 100 is compressed by the delivery device 400 into a sheath 410 having a very small inner diameter and then implanted through the arterial or apical approach, releasing the valve prosthesis 100 when it reaches the aortic root position.
- the valve prosthesis 100 is expanded open, the prosthetic leaflet 210 is distracted, and the valve prosthesis 100 begins to work.
- FIG. 10 is a schematic view of the valve prosthesis implanted in the aorta according to an embodiment of the present invention.
- the body 100 can reach the position of the root of the aorta D through the delivery device 400, that is, the third position W3.
- the valve prosthesis 100 can be released when the position of the valve prosthesis 100 is determined to be appropriate.
- the valve prosthesis 100 is gradually opened, and after complete release, the outflow tract structure 313 of the valve prosthesis 100 is located at the position of the ascending aorta D, that is, the fourth position W4.
- the fourth position W4 Refer to Figure 10.
- the outflow tract structure 313 of the valve prosthesis 100 is located in the ascending aorta D. Due to the great elasticity of the aorta D, the maximum outer diameter of the valve prosthesis 100 is large.
- the tract structure 313 will distract the aorta D, since the volume of the fixed ear 320 of the valve prosthesis 100 is larger and longer than the other mesh tips of the valve prosthesis 100, if the fixed ear is vertically upward, ie the fixed ear is along Parallel to the direction of the central axis of the stent body, the fixed ear is easily punctured or stabbed to the wall of the ascending aorta D, causing serious complications, and therefore, by bending the fixation ear 320 toward the inside of the stent body 310 The fold reduces the risk of the fixation ear 320 piercing the wall of the ascending aorta D. Referring to FIG. 11, FIG. 11, FIG.
- FIG. 11 is a partially enlarged schematic view showing a portion of the valve prosthesis shown in FIG. 10 after implantation into the aorta, and a fixed ear 320 and a tube for ascending aorta D which are bent toward the inside of the stent main body 310.
- the wall has a certain distance, which can effectively avoid the damage of the fixed ear 320 to the wall of the aorta D.
- valve prosthesis 100 When the valve prosthesis 100 is implanted into the aorta D, it is often the case that the release position is not ideal. If the position of the valve prosthesis 100 after implantation of the aortic D is not ideal, it is easy to cause a large reflux of the aorta D, and a valve prosthesis 100 must be implanted again, that is, a midvalvular flap is formed. In the midvalvular valve, the second implanted valve prosthesis 100 is primarily positioned by the support force provided by its outflow tract structure 313.
- FIG. 12 is a schematic view showing a structure in which two valve prostheses are implanted in the aorta according to an embodiment of the present invention, wherein one of the valve prostheses has been implanted Another is in the process of implantation.
- Figure 13 is a schematic illustration of another configuration in which two valve prostheses are implanted in the aorta in one embodiment of the invention, wherein both valve prostheses have been implanted.
- Figure 14 is a partial structural view of the two valve prosthesis B in the first state when the two valve prostheses are implanted in the aorta of Figure 13, and Figure 15 is the two implanted in the aorta in Figure 13 Schematic diagram of the local structure of the two valve prostheses B in the second state in the case of a valve prosthesis.
- the overall structure of the valve prostheses 500 and 600 in this embodiment may be any one of the valve prostheses 100 in the above embodiment, and will not be described herein.
- the second valve prosthesis 600 is located in the first valve prosthesis 500 and the second valve prosthesis 600 is implanted in the aorta D after the first valve prosthesis 500.
- the second valve prosthesis 600 is delivered to the aortic D root, referring to Figure 12, the second valve prosthesis 600 is not released.
- the position of the second valve prosthesis 600 relative to the first valve prosthesis 500 can be adjusted based on image information of the two valve prostheses displayed by the visualization instrument such that the second valve prosthesis 600 is relative to the aorta D and One valve prosthesis 500 is moderately positioned.
- the sheath 410 can be rotated such that the fixation ears 320 of the second valve prosthesis 600 and the fixation ears 320 of the first valve prosthesis 500 are offset by an angle, preferably 30 degrees. Subsequently, the second valve prosthesis 600 is released.
- the fixation ear 320 is bent toward the inside of the stent body 310, after the second valve prosthesis 600 is fully released, the two valve prostheses 100 (ie, the first valve prosthesis 500 and the second valve prosthesis 600)
- the relative positions of at least the following two states exist. Referring to Fig. 14, at this time, the second valve prosthesis 600 is implanted at a high position, and the relative positions of the two valve prostheses 100 are in the first state, that is, the fixed ears 320 of the first valve prosthesis 500 are embedded in the second position.
- the underside of one node P of the valve prosthesis 600 that is, the fixation ear 320 of the first valve prosthesis 500, is embedded in a side of the node P of the second valve prosthesis 600 that is adjacent to the inflow channel structure 311.
- the fixation ear 320 of the first valve prosthesis 500 can be bent toward the inside of the stent body 310, thereby restricting the second valve prosthesis 600 from tilting away from the aorta D, the second valve
- the direction in which the prosthesis 600 is tilted away from the direction of the aorta D can be referred to the second arrow J2 in FIG.
- the second valve prosthesis 600 is a low position implant, and the relative positions of the two valve prostheses 100 are in the second state, that is, the fixed ears 320 of the first valve prosthesis 500 are embedded in the second position.
- the upper side of one node P of the valve prosthesis 600 that is to say the fixation ear 320 of the first valve prosthesis 500, is embedded in the side of a node P of the second valve prosthesis 600 remote from the inflow channel structure 311.
- fixation ear 320 of the first valve prosthesis 500 is bent toward the inside of the stent body 310, thereby restricting the second valve prosthesis 600 from tilting toward the aorta D, the second valve
- the direction in which the prosthesis 600 is tilted toward the direction of the aorta D can be referred to the third arrow J3 in FIG.
- the fixation of the fixation ears 320 of the valve prosthesis 100 to the inside of the stent body 310 limits the freedom of movement of the second valve prosthesis 600 along the axial direction of the valve prosthesis 100 under the condition of the midvalvular flap. It can effectively reduce the risk of displacement of the valve prosthesis 100.
- the Applicant has also proposed a valve prosthesis which is substantially identical to the valve prosthesis of the above embodiment, the difference being the shape and configuration of the fixed ear, where the same is no longer the same.
- the description will mainly introduce the structure of the fixed ear.
- FIG. 16 is a front view of a valve prosthesis according to still another embodiment of the present invention
- FIG. 17 is a partially enlarged schematic view showing a fixing ear according to another embodiment of the present invention.
- the fixing ear also includes the connecting rod and the fixing portion, but the angle at which the fixing ear is bent toward the inner side of the bracket main body in each embodiment may be different in each segment.
- the connecting rod 322 may also be a curved rod.
- the fixing portion 321 extends in a direction close to the central axis of the bracket body 310 at an angle smaller than the connecting line between the two ends of the connecting rod 322 and the center of the bracket body 310.
- the angle between the parallel lines of the axis that is, the angle at which the fixing portion 321 is bent toward the inner side of the holder main body 310 is smaller than the angle at which the connecting rod 322 is bent toward the inner side of the holder main body 310.
- the angle at which the fixing portion 321 is bent toward the inner side of the bracket body 310 is the second angle ⁇ 2 as shown in FIG. 17, and the angle at which the connecting rod 322 is bent toward the inner side of the bracket body 310 is The third angle ⁇ 3.
- the valve prosthesis is compressed at the time of loading, and the fixing lug 320 has only the end portion of the fixing portion 321 and the recess of the fixing head 430. 431, it should be understood by those skilled in the art that at this time, the contact surface of the fixing portion 321 of the single fixing lug 320 and the groove 431 is small for the fixing ear. Therefore, when the valve prosthesis is further loaded into the sheath tube 410, the fixing portion 321 of the fixing lug 320 is easily slipped out of the groove 431.
- the angle at which the fixing portion 321 of the fixing lug 320 extends in a direction close to the central axis of the bracket main body 310 is smaller than the angle between the line between the two end portions of the connecting rod 322 and the direction of the central axis of the bracket main body 310
- the fixing ear 320 is fixed.
- the abutting surface of the fixing portion 321 and the groove 431 can be increased, thereby preventing the fixing portion 321 of the fixing ear 320 from slipping out of the groove 431 when the valve prosthesis is loaded into the sheath tube, thereby further reducing Loading difficulty and improving loading efficiency.
- FIG. 18 is a schematic structural view of a valve prosthesis implanted in the aorta according to still another embodiment of the present invention.
- the fixing portion 321 is attached to the stent.
- the angle of the inner side of the main body 310 is bent less than the angle between the line connecting the two ends of the connecting rod 322 and the parallel line of the central axis of the bracket body 310, so that the two fixing ears 320 can be prevented from being away from the valve prosthesis
- One end of the inflow channel structure is too close so that the fixation ear of the first valve prosthesis 500 can be prevented from interfering with the second valve prosthesis 600 or with the delivery device delivering the second valve prosthesis 600.
- the angle at which the fixing portion 321 is bent toward the inner side of the bracket body 310 may be greater than or equal to the angle at which the connecting rod 322 is bent toward the inner side of the bracket body 310.
- the connecting rod includes a first connecting section 324 and a second connecting section 325.
- One end of the first connecting section 324 is connected to the bracket body 310, and the other end of the first connecting section 324 is connected to one end of the second connecting section 325, the first connecting section 324 and the bracket One end of the body 310 is connected to the first connection end 320a.
- the other end of the second connecting section 325 is connected to the fixing portion.
- the first connecting section 324 forms a first bending section of the fixing ear 320
- the second connecting section 325 forms a second bending section of the fixing ear 320, the first connecting section 324 and the second
- the angle at which the connecting section 325 is bent toward the inner side of the bracket body 310 may be the same or different.
- the angle at which the second connecting portion 325 is bent toward the inner side of the bracket main body 310 is greater than the angle at which the first connecting portion 324 is bent toward the inner side of the bracket main body 310, or the second connection
- the angle at which the segment 325 is bent toward the inner side of the stent body 310 is smaller than the angle at which the first connecting segment 324 is bent toward the inner side of the stent body 310.
- the second connecting portion 325 and the fixing portion 321 together form a second bending portion of the fixing ear, that is, the first connecting portion 324 is directed to the bracket.
- An angle at which the inner side of the main body 310 is bent is larger than an angle at which the second connecting portion 325 is bent toward the inner side of the bracket main body 310, and the second connecting portion 325 is bent toward the inner side of the bracket main body 310.
- the angle is the same as the angle at which the fixing portion 321 is bent toward the inner side of the bracket body 310, that is, the fixing ear 320 occurs at the junction of the first connecting portion 324 and the second connecting portion 325.
- the bending is performed, and the second connecting portion 325 and the fixing portion 321 are bent at a predetermined angle in a direction away from the central axis of the bracket main body 310.
- the angle at which the first bending segment is bent toward the inner side of the bracket body 310 ranges from 10° to 45°, and the second bending segment is bent toward the inner side of the bracket body 310.
- the angle ranges from 5° to 40°. More preferably, the angle at which the second bending section is bent toward the inner side of the bracket body 310 ranges from 15° to 30°.
- FIG. 19 is a front view of a valve prosthesis according to another embodiment of the present invention.
- the main difference between the valve prosthesis 100 of the present embodiment and the valve prosthesis 100 of the first embodiment is that the embodiment The plurality of fixation ears 320 of the valve prosthesis 100 can be made by weaving.
- the plurality of fixing ears 320 can be made by multi-layer knitting.
- the fixing ears 320 made by other methods are softer, such as softer than the fixing ears 320 made by cutting, when When the fixing ear 320 is in contact with the wall of the aorta D, the fixing ear 320 can be easily squeezed, so that the fixing ear 320 is bent toward the inner side of the stent body 310 without damaging the wall of the aorta D, thereby reducing the fixation. The risk of the ear 320 piercing the wall of the aorta D.
- the fixing ear 320 formed by the multi-layer weaving method is larger than the thickness of the fixing ear 320 which is formed by cutting, the fixing ear 320 can be conveniently fixed to the conveying device 400, thereby facilitating the fake valve.
- the body 100 is loaded into the delivery device 400.
- the multi-layer woven valve prosthesis 100 is relatively soft, the difficulty of folding the fixation ear 320 and securing the fixation ear 320 in the delivery device 400 when loading the valve prosthesis 100 into the sheath tube 410 can be reduced. Saving the loading time of the valve support 300 can increase the loading efficiency of the valve support 300.
- the stent body 310 and the fixing ears 320 of the valve prosthesis 100 are both made by weaving.
- the plurality of fixing ears 320 may be integrally woven with the bracket body 310, or may be separately woven and then welded to the bracket body 310.
- the stent body 310 of the valve prosthesis 100 can be formed in other ways.
- the plurality of fixing ears 320 can be bent toward the inner side of the bracket body 310 by means of mold setting.
- the fixing lug 320 has an L-shape, that is, the fixing lug 320 first extends toward the inner side of the bracket main body 310 along the radial direction of the bracket main body 310, and then moves away from the axial direction of the bracket main body 310.
- the direction of the outflow channel structure 313 extends.
- the plurality of fixing ears 320 can extend parallel to the axial direction of the bracket body 310 in a direction away from the outflow channel structure 313.
- This embodiment provides a valve prosthesis.
- the main difference between the valve prosthesis of the embodiment and the valve prosthesis of the first embodiment is that in the embodiment, the plurality of fixing ears of the valve prosthesis can be made by cutting, and the main body of the stent is woven. Made in a way.
- FIG. 20 is a front view of a valve prosthesis according to still another embodiment of the present invention
- FIG. 21 is a partially enlarged schematic view showing a fixed ear of a valve prosthesis according to still another embodiment of the present invention.
- the main difference between the valve prosthesis of the embodiment and the valve prosthesis of the first embodiment is that in the present embodiment, the plurality of fixing ears 320 of the valve prosthesis 100 can be made by weaving.
- the fixing ear 320 has a through hole 323.
- the through hole 323 is preferably located at the center of the fixing portion 321 of the fixing ear 320.
- the thickness of the fixing lug 320 is preferably greater than the thickness of the bracket body 310.
- FIG. 22 is a partially enlarged schematic view of a conveying device in another embodiment of the present invention.
- a boss 433 may be disposed at the bottom 432 of the recess 431 of the fixing head 430 of the conveying device 400.
- the boss 433 preferably matches the through hole 323 of the fixing lug 320.
- the boss 433 of the bottom portion 432 is so that the fixing ears 320 of the valve prosthesis 100 are slightly compressed to bring the fixing ears 320 into contact with the bottom 432 of the recess 431 of the fixing head 430, thereby facilitating loading of the fixing ears 320 to In the sheath 410.
- valve stent, the valve prosthesis and the conveying device provided by the invention can achieve the following effects by bending the fixed ear to the inner side of the stent body:
- the fixation of the fixed ear of the valve prosthesis to the inside of the stent body limits the freedom of movement of the second valve prosthesis along the axial direction of the valve prosthesis under the condition of the midvalvular flap, which can effectively reduce the valve prosthesis The risk of shifting.
Landscapes
- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
L'invention concerne une endoprothèse de valvule (300), une prothèse de valvule (100) et un dispositif de pose (400). L'endoprothèse de valvule (300) comprend : un corps d'endoprothèse (310), le corps d'endoprothèse (310) étant tubulaire en maille ; et une pluralité de pattes de fixation (320), la pluralité de pattes de fixation (320) étant disposées sur le corps d'endoprothèse (310) et pliées vers le côté interne du corps d'endoprothèse (310). La prothèse de valvule (100) comprend une valvule artificielle (200) et l'endoprothèse de valvule (300). La valvule artificielle (200) est fixée sur l'endoprothèse de valvule (300). Le dispositif de pose (400) est utilisé pour poser la prothèse de valvule (100). Le dispositif de pose (400) comprend une gaine (410), un tube interne (420), une tête fixe (430) et un tube de guidage (440). La gaine (410) est utilisée pour recevoir la prothèse de valvule (100). La tête fixe (430) est utilisée pour définir les positions des pattes de fixation (320) de la prothèse de valvule (100) par rapport au tube interne (420). Le tube de guidage (440) est utilisé pour serrer les pattes de fixation (320) de la prothèse de valvule (100) sur la tête fixe (430). L'endoprothèse de valvule (300), la prothèse de valvule (100) et le dispositif de pose (400) peuvent améliorer l'efficacité de chargement de la prothèse de valvule (100).
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
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ES18877449T ES2968281T3 (es) | 2017-11-17 | 2018-11-06 | Stent valvular, prótesis valvular y dispositivo de colocación |
EP18877449.1A EP3711716B1 (fr) | 2017-11-17 | 2018-11-06 | Endoprothèse de valvule, prothèse de valvule et dispositif de pose |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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CN201711148589.X | 2017-11-17 | ||
CN201711148589.XA CN109793596B (zh) | 2017-11-17 | 2017-11-17 | 瓣膜支架、瓣膜假体和输送装置 |
Publications (1)
Publication Number | Publication Date |
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WO2019096033A1 true WO2019096033A1 (fr) | 2019-05-23 |
Family
ID=66538502
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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PCT/CN2018/114215 WO2019096033A1 (fr) | 2017-11-17 | 2018-11-06 | Endoprothèse de valvule, prothèse de valvule et dispositif de pose |
Country Status (4)
Country | Link |
---|---|
EP (1) | EP3711716B1 (fr) |
CN (1) | CN109793596B (fr) |
ES (1) | ES2968281T3 (fr) |
WO (1) | WO2019096033A1 (fr) |
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US11166814B2 (en) | 2019-08-20 | 2021-11-09 | Vdyne, Inc. | Delivery and retrieval devices and methods for side-deliverable transcatheter prosthetic valves |
US11173027B2 (en) | 2019-03-14 | 2021-11-16 | Vdyne, Inc. | Side-deliverable transcatheter prosthetic valves and methods for delivering and anchoring the same |
US11185409B2 (en) | 2019-01-26 | 2021-11-30 | Vdyne, Inc. | Collapsible inner flow control component for side-delivered transcatheter heart valve prosthesis |
US11202706B2 (en) | 2019-05-04 | 2021-12-21 | Vdyne, Inc. | Cinch device and method for deployment of a side-delivered prosthetic heart valve in a native annulus |
US11234813B2 (en) | 2020-01-17 | 2022-02-01 | Vdyne, Inc. | Ventricular stability elements for side-deliverable prosthetic heart valves and methods of delivery |
US11253359B2 (en) | 2018-12-20 | 2022-02-22 | Vdyne, Inc. | Proximal tab for side-delivered transcatheter heart valves and methods of delivery |
US11273033B2 (en) | 2018-09-20 | 2022-03-15 | Vdyne, Inc. | Side-delivered transcatheter heart valve replacement |
US11273032B2 (en) | 2019-01-26 | 2022-03-15 | Vdyne, Inc. | Collapsible inner flow control component for side-deliverable transcatheter heart valve prosthesis |
US11278437B2 (en) | 2018-12-08 | 2022-03-22 | Vdyne, Inc. | Compression capable annular frames for side delivery of transcatheter heart valve replacement |
US11298227B2 (en) | 2019-03-05 | 2022-04-12 | Vdyne, Inc. | Tricuspid regurgitation control devices for orthogonal transcatheter heart valve prosthesis |
US11331186B2 (en) | 2019-08-26 | 2022-05-17 | Vdyne, Inc. | Side-deliverable transcatheter prosthetic valves and methods for delivering and anchoring the same |
US11344413B2 (en) | 2018-09-20 | 2022-05-31 | Vdyne, Inc. | Transcatheter deliverable prosthetic heart valves and methods of delivery |
US11786366B2 (en) | 2018-04-04 | 2023-10-17 | Vdyne, Inc. | Devices and methods for anchoring transcatheter heart valve |
US12186187B2 (en) | 2018-09-20 | 2025-01-07 | Vdyne, Inc. | Transcatheter deliverable prosthetic heart valves and methods of delivery |
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CN114515213A (zh) * | 2020-11-20 | 2022-05-20 | 深圳市健心医疗科技有限公司 | 人工瓣膜和人工瓣膜系统 |
CN113662716B (zh) * | 2021-09-27 | 2024-10-11 | 广东脉搏医疗科技有限公司 | 一种植入三尖瓣膜装置 |
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US11344413B2 (en) | 2018-09-20 | 2022-05-31 | Vdyne, Inc. | Transcatheter deliverable prosthetic heart valves and methods of delivery |
US12186187B2 (en) | 2018-09-20 | 2025-01-07 | Vdyne, Inc. | Transcatheter deliverable prosthetic heart valves and methods of delivery |
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US11071627B2 (en) | 2018-10-18 | 2021-07-27 | Vdyne, Inc. | Orthogonally delivered transcatheter heart valve frame for valve in valve prosthesis |
US11109969B2 (en) | 2018-10-22 | 2021-09-07 | Vdyne, Inc. | Guidewire delivery of transcatheter heart valve |
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Also Published As
Publication number | Publication date |
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CN109793596A (zh) | 2019-05-24 |
EP3711716A4 (fr) | 2021-01-06 |
EP3711716B1 (fr) | 2024-01-03 |
ES2968281T3 (es) | 2024-05-08 |
EP3711716A1 (fr) | 2020-09-23 |
CN109793596B (zh) | 2025-03-28 |
EP3711716C0 (fr) | 2024-01-03 |
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